tramadol hydrochloride

Generic: tramadol hydrochloride

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tramadol hydrochloride
Generic Name tramadol hydrochloride
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tramadol hydrochloride 50 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-865
Product ID 71610-865_27460b14-190b-94e9-e063-6394a90ae97f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075977
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2002-06-19

Pharmacologic Class

Classes
full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610865
Hyphenated Format 71610-865

Supplemental Identifiers

RxCUI
835603
UNII
9N7R477WCK

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tramadol hydrochloride (source: ndc)
Generic Name tramadol hydrochloride (source: ndc)
Application Number ANDA075977 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 15 TABLET, FILM COATED in 1 BOTTLE (71610-865-15)
  • 20 TABLET, FILM COATED in 1 BOTTLE (71610-865-20)
  • 224 TABLET, FILM COATED in 1 BOTTLE (71610-865-24)
  • 28 TABLET, FILM COATED in 1 BOTTLE (71610-865-28)
  • 30 TABLET, FILM COATED in 1 BOTTLE (71610-865-30)
  • 40 TABLET, FILM COATED in 1 BOTTLE (71610-865-40)
  • 45 TABLET, FILM COATED in 1 BOTTLE (71610-865-45)
  • 56 TABLET, FILM COATED in 1 BOTTLE (71610-865-46)
  • 50 TABLET, FILM COATED in 1 BOTTLE (71610-865-50)
  • 60 TABLET, FILM COATED in 1 BOTTLE (71610-865-53)
  • 84 TABLET, FILM COATED in 1 BOTTLE (71610-865-54)
  • 80 TABLET, FILM COATED in 1 BOTTLE (71610-865-57)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71610-865-60)
  • 100 TABLET, FILM COATED in 1 BOTTLE (71610-865-65)
  • 168 TABLET, FILM COATED in 1 BOTTLE (71610-865-67)
  • 120 TABLET, FILM COATED in 1 BOTTLE (71610-865-70)
  • 112 TABLET, FILM COATED in 1 BOTTLE (71610-865-72)
  • 135 TABLET, FILM COATED in 1 BOTTLE (71610-865-73)
  • 150 TABLET, FILM COATED in 1 BOTTLE (71610-865-75)
  • 180 TABLET, FILM COATED in 1 BOTTLE (71610-865-80)
  • 200 TABLET, FILM COATED in 1 BOTTLE (71610-865-85)
  • 240 TABLET, FILM COATED in 1 BOTTLE (71610-865-90)
  • 270 TABLET, FILM COATED in 1 BOTTLE (71610-865-92)
source: ndc

Packages (23)

71610-865-15 15 TABLET, FILM COATED in 1 BOTTLE (71610-865-15) 71610-865-20 20 TABLET, FILM COATED in 1 BOTTLE (71610-865-20) 71610-865-24 224 TABLET, FILM COATED in 1 BOTTLE (71610-865-24) 71610-865-28 28 TABLET, FILM COATED in 1 BOTTLE (71610-865-28) 71610-865-30 30 TABLET, FILM COATED in 1 BOTTLE (71610-865-30) 71610-865-40 40 TABLET, FILM COATED in 1 BOTTLE (71610-865-40) 71610-865-45 45 TABLET, FILM COATED in 1 BOTTLE (71610-865-45) 71610-865-46 56 TABLET, FILM COATED in 1 BOTTLE (71610-865-46) 71610-865-50 50 TABLET, FILM COATED in 1 BOTTLE (71610-865-50) 71610-865-53 60 TABLET, FILM COATED in 1 BOTTLE (71610-865-53) 71610-865-54 84 TABLET, FILM COATED in 1 BOTTLE (71610-865-54) 71610-865-57 80 TABLET, FILM COATED in 1 BOTTLE (71610-865-57) 71610-865-60 90 TABLET, FILM COATED in 1 BOTTLE (71610-865-60) 71610-865-65 100 TABLET, FILM COATED in 1 BOTTLE (71610-865-65) 71610-865-67 168 TABLET, FILM COATED in 1 BOTTLE (71610-865-67) 71610-865-70 120 TABLET, FILM COATED in 1 BOTTLE (71610-865-70) 71610-865-72 112 TABLET, FILM COATED in 1 BOTTLE (71610-865-72) 71610-865-73 135 TABLET, FILM COATED in 1 BOTTLE (71610-865-73) 71610-865-75 150 TABLET, FILM COATED in 1 BOTTLE (71610-865-75) 71610-865-80 180 TABLET, FILM COATED in 1 BOTTLE (71610-865-80) 71610-865-85 200 TABLET, FILM COATED in 1 BOTTLE (71610-865-85) 71610-865-90 240 TABLET, FILM COATED in 1 BOTTLE (71610-865-90) 71610-865-92 270 TABLET, FILM COATED in 1 BOTTLE (71610-865-92)

Ingredients (1)

tramadol hydrochloride (50 mg/1)

Linked Drug Pages (1)

Tramadol Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
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